22h ago

Documents Specialist II

Bangalore, Karnataka, India

โœจ $35k-$50k / yearest.

full-timesenior Remotehealthcare

๐Ÿ›  Tech Stack

๐Ÿ’ผ About This Role

You'll prepare TMF plans and perform document QC and indexing for clinical trials in a fully remote role. Your work ensures timely document processing and compliance with GCP and regulatory guidelines. You'll collaborate globally on studies for oncology and rare diseases.

๐ŸŽฏ What You'll Do

  • Perform document QC and indexing within eTMF for assigned studies
  • Monitor document submission and timely processing to avoid backlogs
  • Distribute TMF metrics to stakeholders
  • Manage close-out activities including eTMF export and client transfer

๐Ÿ“‹ Requirements

  • 4-year college degree or equivalent in business, scientific, or healthcare discipline
  • Minimum 5 years of clinical trial experience
  • Minimum 3 years of experience with TMF and/or eTMF
  • Proficiency in Microsoft Office (Outlook, Word, Excel, PowerPoint)

โœจ Nice to Have

  • Working knowledge of ICH-GCP and regulatory guidance
  • Experience with oncology or rare disease trials

๐ŸŽ Benefits & Perks

  • ๐Ÿ–๏ธ Remote work flexibility
  • ๐Ÿฅ Health insurance
  • ๐Ÿ“ˆ Professional development opportunities
  • ๐Ÿ’ฐ Competitive compensation
  • ๐ŸŽ‰ Collaborative team environment

๐Ÿ“จ Hiring Process

Estimated timeline: 2-4 weeks ยท AI estimate

  1. 1Phone Screenยท 30 min
  2. 2Technical Interviewยท 45 min
  3. 3Hiring Manager Interviewยท 45 min
0 0 0